Injection monitoring device

Abstract

Drug delivery systems, devices and methods of use for recording a drug dose completion signal in a data management system are provided. Aspects of the invention include drug delivery systems comprising a syringe stopper rod that comprises a sensor component comprising a wireless transmitter module and an activation component configured to activate the sensor component when the syringe stopper rod has completed a delivery stroke, wherein the wireless transmitter module is configured to transmit a report comprising a drug dose completion signal when the sensor component is activated.

What is claimed is: 
     
       1. A syringe stopper rod comprising:
 a rod portion having a proximal end and a distal end; 
 a stopper located at the distal end of the rod portion; 
 a thumb pad located at the proximal end of the rod portion; and 
 an activation component located adjacent to the thumb pad, 
 wherein the stopper and the rod portion are configured to be received within a barrel of a syringe during use and the thumb pad is configured to manually drive the stopper and rod portion distally into the syringe barrel, 
 wherein the thumb pad includes a sensor component comprising: 
 a battery; 
 a printed circuit board assembly; and 
 a wireless transmitter module, 
 wherein the entire sensor component resides on the thumb pad, 
 wherein the activation component is configured to activate the sensor component when the syringe stopper rod has completed a delivery stroke in a syringe barrel, 
 wherein the wireless transmitter module is configured to transmit a report comprising a drug dose completion signal when the sensor component is activated. 
 
     
     
       2. A syringe system comprising:
 the syringe stopper rod according to  claim 1 ; and 
 a syringe barrel. 
 
     
     
       3. The syringe system according to  claim 2 , wherein the syringe barrel is pre-filled with a medication before being sold to a consumer. 
     
     
       4. The syringe system according to  claim 2 , further comprising a needle coupled to a distal end of the syringe barrel. 
     
     
       5. The syringe system according to  claim 4 , wherein the syringe barrel comprises a needle safety device configured to sequester the needle upon completion of a delivery stroke of the syringe stopper rod in the syringe barrel. 
     
     
       6. A drug delivery system comprising:
 the syringe system according to  claim 2 ; and 
 a data management system configured to receive and record the report from the sensor component. 
 
     
     
       7. The drug delivery system according to  claim 6 , wherein the drug delivery system further comprises a nonvolatile memory component that is encoded with at least one drug identification characteristic. 
     
     
       8. The drug delivery system according to  claim 6 , wherein the nonvolatile memory component is located within the thumb pad. 
     
     
       9. The drug delivery system according to  claim 6 , wherein the data management system comprises a smart phone having a computer application configured to record administration of a drug dose to a patient. 
     
     
       10. The drug delivery system according to  claim 6 , wherein the report comprises at least one item selected from the group consisting of a drug temperature value, a dose amount, a dose administration time stamp, a geographical location, an anatomical location, and a drug authentication signal. 
     
     
       11. The drug delivery system according to  claim 6 , wherein the report comprises a drug authentication signal and wherein the drug authentication signal comprises at least one drug identification characteristic selected from the group consisting of a drug name, a drug concentration, a drug dose, a drug dosage, a serial number, a lot number, an expiration date and a manufacturing site. 
     
     
       12. The drug delivery system according to  claim 6 , wherein the report comprises a drug authentication signal and wherein the data management system is configured to validate the drug authentication signal. 
     
     
       13. The drug delivery system according to  claim 6 , wherein the report comprises a drug authentication signal and wherein the data management system is configured to utilize the drug authentication signal to obtain one or more additional drug identification characteristics. 
     
     
       14. The drug delivery system according to  claim 13 , wherein the data management system is configured to transmit the drug authentication signal to a remote database and receive the one or more additional drug identification characteristics in response. 
     
     
       15. A method for recording administration of a drug dose to a patient, the method comprising:
 inserting the needle of the drug delivery system according to  claim 6  into the patient; 
 completing a delivery stroke of the syringe stopper rod, thereby causing the activation component to activate the sensor component, and causing the wireless transmitter module to transmit a report comprising a drug dose completion signal to the data management system; and 
 receiving and recording the report in the data management system, thereby recording administration of the drug dose to the patient. 
 
     
     
       16. The method for recording administration of a drug dose to a patient according to  claim 15 , further comprising:
 transmitting a drug authentication signal in the report transmitted by the wireless transmitter module to the data management system; and 
 validating the drug authentication signal with the data management system. 
 
     
     
       17. The method for recording administration of a drug dose to a patient according to  claim 15 , further comprising:
 transmitting a drug authentication signal in the report transmitted by the wireless transmitter module to the data management system; and 
 utilizing the drug authentication signal with the data management system to obtain one or more additional drug identification characteristics. 
 
     
     
       18. The method for recording administration of a drug dose to a patient according to  claim 17 , further comprising:
 transmitting the drug authentication signal from the data management system to a remote database; and 
 receiving the one or more additional drug identification characteristics in response. 
 
     
     
       19. The syringe system according to  claim 2 , further comprising an indicator component. 
     
     
       20. The syringe system according to  claim 19 , wherein the indicator component is configured to indicate at least one state to a user, the at least one state selected from the group consisting of a ready state, an unready state, a dose-in-progress state, a dose completed state, a sleep mode and a low battery state. 
     
     
       21. The syringe system according to  claim 20 , wherein the indicator component comprises at least one component selected from the group consisting of a visual indicator component, a haptic indicator component and an auditory indicator component. 
     
     
       22. The syringe system according to  claim 21 , wherein the indicator component comprises at least one visual indicator component selected from the group consisting of a light-emitting component, a light emitting diode (LED), an organic light-emitting diode (OLED), a light pipe and a light pipe diffuser. 
     
     
       23. The syringe system according to  claim 21 , wherein the indicator component comprises a haptic indicator component that includes a vibration component. 
     
     
       24. The syringe system according to  claim 2 , wherein the sensor component comprises a non-volatile memory component and the non-volatile memory component comprises at least one drug identification characteristic. 
     
     
       25. The syringe system according to  claim 24 , wherein the at least one drug identification characteristic is selected from the group consisting of a drug name, a drug concentration, a drug dose, a drug dosage, a serial number, a lot number, an expiration date and a manufacturing site.